This project is part of the EDCTP2 Programme supported by the European Union.

Work packages

Work package 1: Project coordination

The coordination and overall management activities of SINDOFO project are described in WP1 led by EKUT. Responsibilities include coordination of work packages’ activities, ensuring effective communication between all partners, reporting and communicating with EDCTP. The successful and efficient coordination will be supported by a project management team located at EKUT, Germany assisted by project managers at the clinical trial sites and the European partners ISGlobal and MMV.

WP1 includes further tasks such as data management, networking, financial management, dissemination and communication activities. The data management plan will be developed within the first 18 months after project start in close cooperation with the clinical trial sponsor, the 4 clinical trial sites in this consortium (and their European partners, ISGlobal and EKUT). Networking will target intra-consortium activities to strengthen north-south contacts as well as south-south collaboration and beyond the consortium via MMV.

Work packages 2 to 5: Phase II clinical trial

The core of SINDOFO project is the multicenter phase II clinical trial conducted at the 4 African partner sites that represent four different geographical areas of Africa (East, West, Central and South). The workload of this phase II trial is organized into 4 work packages

(WP 2-5) to facilitate clinical study management.

The clinical trial will assess the efficacy and safety of different treatment regimens of FQ+MMV253 in African adults and paediatric patients with uncomplicated P. falciparum malaria. The regulatory sponsorship will be performed by MMV.

The clinical trial will be conducted according to ICH-GCP standards and qualified clinical monitors will monitor the conduct of the trials ensuring the compliance with the ICH-GCP standards as well as with all ethical standards. Monitoring will include quality control and quality assurance as well as source document verification and inspection of the relevant facilities.

Work package 6: Capacity building and infrastructure upgrading

Capacity building and training activities will be performed within WP6 led by CERMEL, Gabon, together with ISGlobal, Spain. This includes the development and upgrading of the appropriate infrastructure for the clinical trial sites and training of personnel for the clinical studies e.g. physicians, study nurses but also personnel for data management and QC, as well as PhD student and postdoc training.